Kornimate/medical-research-clean huggingface dataset:
effect of collagen supplementation on tendinopathy

Conditions: Tendinopathy

Summary: tendon injuries represent a significant problem in elite athletes. therefore, prevention and effective treatment of tendon overload injury/tendinopathy is important. among different treatment options, heavy-slow loading based rehabilitation is considered among the most efficient treatments in athletes. in this study, we will investigate if supplementation with hydrolyzed collagen in combination with a heavy-slow loading based 12 weeks rehabilitation regime can improve treatment of tendon overload injury/tendinopathy. the investigators will examine elite athletes with overload injury/tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography), and vascularization (doppler us). the investigators hypothesize that collagen supplementation can have an improving effect on tendon pain and function. thus, the investigation will show if a rehabilitation regime of collagen supplementation combined with heavy-slow mechanical loading can improve tendon healing compared to mechanical loading alone.

randomized placebo-controlled intervention study with follow-up after one month

Eligibility criteria:
inclusion criteria: * elite athletes * 18-40 years old * exercise related tendon pain on one or both legs * soreness during physical examination of tendon upon palpation * uni- or bilateral tendinopathy symptoms \> 3 months exclusion criteria: * previous tendon surgery * diabetes * arthritis * corticosteroid injection for tendinopathy within the last 3 months * any form of tendon injection within the last 3 months * smoking
toxicity comparison between hypofractionated radiotherapy with hdr brachytherapy boost versus standard treatment

Conditions: Prostate Cancer

Summary: the purpose of this study is to compare toxicities between 2 external beam radiation fractionation schemes plus a brachytherapy boost for prostate cancer. our current standard use a 2 gy per fraction schedule which is compare to the experimental hypofractionated 3 gy per day approach with neo adjuvant hormonal therapy. it will demonstrate the feasibility and safety of such a treatment regimen in prostate cancer. it may also set base for a larger randomized trial.

30 patients with intermediate / extensive low risk (all core biopsies involvements \> 50%) prostate cancer (not necessitating to treat the nodal regions) will be included in this study. patient stage t1 - t2, gleason score ≤ 7, prostate-specific antigen (psa) ≤ 20 will be considered. fiducial gold markers will be introduced in the prostate 1-week before the ct planning. 36 gray (gy) in 12 fractions using intensity-modulated radiation therapy (imrt) will be administered to the prostate (margins of 0,5cm) +/- first centimeter of the seminal vesicles. brachytherapy boost (15 gy x 1) dosimetric parameters should respect our current standard (prostate v100 \> 90% and v150 ≤ 40%, v200 ≤ 15%, urethra v125 ≤ 1 cc, rectum v75 ≤ 1cc, bladder v75 ≤ 1cc). short course (4 months) hormonal therapy (degarelix) will be administered to the patient based upon recommended litterature11, 12. genitourinary (gu), gi and sexual toxicity will be self reported. qol questionnaires will be given to the patients to be answered. results will be monitored and compared to our currently used standard fractionation regiment. follow-up will be scheduled 6 weeks after the implant and every 4 months for the first year, every 6 months for the second year 2 to 5, and on a yearly basis after 5 years. psa \& testosterone tests will be done every 3 months for the first 3 years, every 6 months on years 4 and 5, and yearly thereafter.

Eligibility criteria:
inclusion criteria: * 30 patients * intermediate / extensive low risk (all core biopsies involvements \> 50%) * prostate cancer (not necessitating to treat the nodal regions) * patient stage t1 - t2, * gleason score ≤ 7, * psa ≤ 20 will be considered exclusion criteria: * patient unfit for biopsy or brachytherapy * high or low risk prostate cancer

Keywords: prostate cancer brachytherapy hypofractionated radiation therapy hormonal therapy
slow yogic-derived breathing and respiration and cardiovascular variability in spinal cord injury patients

Conditions: Spinal Cord Injuries; Slow Breathing

Summary: this research will aid in understanding of slow-breathing and its effect on heart rate and blood pressure in people with a spinal cord injury (sci). this research will investigate if traditional 'yogic' breathing exercises can be performed by subjects with sci and its influence on the cardiovascular system.

the relationship between respiratory patterns and cardiovascular variability in healthy persons has been previously studied. however, the impact of sci on the interrelationships between the respiratory and cardiovascular systems remains relatively unstudied. the loss of autonomic control in sci may mean that slow breathing has profound effects on cardiovascular variability. hence, those with sci may represent a population that could benefit from the potential physiologic effects of numerous yogic-based breathing patterns that can be applied anywhere any time. hence, it is important to determine if slower breathing patterns can shift the cardiovascular control pattern to-wards important healthful effects. this physiological study will compare the effects of uncontrolled breathing and traditional yogic slow-breathing practices on cardiovascular variability in sci patients.

Eligibility criteria:
inclusion criteria: 1. age: 18-60 years old 2. wheelchair user 3. medically stable \& able to follow directions 4. body mass index (18.5 - 35 kg/m2) exclusion criteria: 1. bp \>140/90 mmhg 2. current use of cardioactive medications (except medication to support blood pressure) 3. current tobacco use 4. significant arrhythmia 5. coronary artery disease 6. diabetes 7. renal disease 8. cancer 9. epilepsy or other neurological diseases

Keywords: resonance yogic pranayama spinal cord injury
variance of hrd from paired ovarian cancer

Conditions: Ovarian Cancer; HRD; Platinum-sensitive Ovarian Cancer

Summary: homologous recombination deficiency (hrd) is an important biomarker of poly (adp-ribose) polymerase inhibitor (parpi) in patients with high-grade serous ovarian cancer (hgsoc). the stability of hrd in the recurrent hgsoc and its primary pair remains unknown.

this study intends to perform hrd testing of ovarian cancer in the recurrent hgsoc and its primary pair, furtherly correlate hrd status and clinical characteristics in the recurited population.

Eligibility criteria:
inclusion criteria: 1. subjects join the study voluntarily and sign informed consent; 2. female subjects are older than 18 years; 3. ecog(eastern cooperative oncology group) physical status score is 0-2; 4. life expectancy≥3 months; 5. histologically confirmed figo(international federation of gynecology and obstetrics ) iii/iv ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; participants must have high-grade serous histology exclusion criteria: 1. personnel involved in the formulation or implementation of the research plan; 2. the subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;
night hyperglycemia and fatty liver in type 1 diabetes

Conditions: Type1diabetes; Fatty Liver

Summary: this clinical trial aims to discover the relationship between hyperglycemia at night and early morning hours and the presence of fatty liver in patients with type 1 diabetes. the main question it aims to answer are: • if hyperglycemic patterns related to metabolic parameters in type 1 diabetes the data from the insulin pump and sensor will be processed. the patients will be divided into two groups. one group without night hyperglycemia and the other with night hyperglycemia. investigators will perform liver elastography for these two groups. the presence or absence of hepatic steatosis will be evaluated in these groups according to the data.

introduction normal subjects have well-defined 24-hour cycles of insulin secretion and plasma insulin levels (rising in the early morning, peaking in the afternoon, and declining at night. the dawn phenomenon is the result of an exaggeration of the physiologic impairment of insulin sensitivity was noted during the early morning hours. during previous studies, no exact explanation of this phenomenon was found. according to the studies, high growth hormone levels with decreased suppression by hyperglycemia, central hypersensitivity to growth hormone-releasing hormone (ghrh), low insulin-like growth factor-i (igf-i), high insulin-like growth factor-binding protein-1 (igfbp-1), and peripheral resistance to growth hormone are involved in the pathogenesis of dawn syndrome. the etiology, prevalence, and consequences of hepatic steatosis in type 1 diabetes remain poorly understood. methods the study will include 120 consecutive patients with type 1 diabetes, using an insulin pump and continuous glucose monitoring device treated in our clinic. investigators will extract the data related to glucose levels and pump programming. the data about glucose levels and insulin requirements during the night hours will be collected. the study participants will be divided into two groups according to the presence or absence of night hyperglycemia. we will perform liver elastography on 100 study patients.

Eligibility criteria:
inclusion criteria: * type 1 diabetes patients * c- peptide level \<0.6 * continuous glucose monitoring system * insulin pump users exclusion criteria: * pregnancy * type 2 diabetes * non-pump or sensor users * unwilling to participate

Keywords: type 1 diabetes
van assessment tool in the treatment of acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: to investigate the reliability of van tool as administered by emergency medical services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction

the investigators propose to perform a 6-month pilot study in northwest arkansas in collaboration of two ems providers; central ems and airevac. these local providers operate in the wrmc catchment area and transport over 90% of patients with a suspected stroke to wrmc comprehensive stroke center. thus no changes to their standard operations would be implemented. the aim of this pilot study would be to test the accuracy of van-screening in the area in patients treated at wrmc - thus only patients who are brought to wrmc as per current protocol would be included in the study. the investigators would train central ems and airevac personnel to perform the v.a.n screen, over a 2-month period (estimated june-july 2020) in several sessions at the central ems training center at 800 s. school ave. in fayetteville. this training would be performed by study investigators, assisted by medical students, residents, and advanced practice nurses (apns). the training would consist of a training video, hands-on instruction, and sample scenarios.the investigators would survey all training participants to gather feedback on the format, delivery, and understanding of the training material. the powerpoint presentation planned for the training session, as well as the post-training quiz, are attached as appendices to this application. the investigators would expect a rate of 80% correct answers in the post-training quiz. all questions and scenarios would be discussed with all trainees after the quiz, and re-takes would be allowed.

Eligibility criteria:
inclusion criteria: * patients treated for stroke at wrmc who are transported to the hospital by central ems or airevac exclusion criteria: * stroke patients who arrive directly to the hospital (without the use of ems services)
a phase ii study of medi-507, administered by injection to adults with psoriasis

Conditions: Plaque Psoriasis

Summary: to compare disease activity, as measured by pasi score, of three medi-507 dosing (injection)regimens vs. placebo.

the primary objective of this study is to compare disease activity, as measured by pasi score, of three medi-507 dosing regimens (5 mg for 12 weeks, 5 mg for 6 weeks, 7 mg for 4 weeks) versus placebo administered weekly by sc injection.

Eligibility criteria:
inclusion criteria: * plaque psoriasis involving at least 10% of body surface area * age 18 through 65 years at the time of the first dose of study drug * both males and females are eligible. however, sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, iud, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of study drug and must agree to continue * currently receiving no therapy for psoriasis except emollients (certain other over-the-counter products may be allowed with prior approval of the sponsor) * written informed consent obtained from the patient * ability to complete follow-up period of 167 days as required by the protocol exclusion criteria: * pustular, guttate, or erythrodermic psoriasis as the predominant disease type * pasi score \<8 * at screening (must be within 21 days before study entry) any of the following: lymphocyte count under 1,200 cells/mm3, wbc under 4,000 cells/mm3, hematocrit below 32%, platelets below 110,000 cells/mm3, creatinine, ast, alt over 1.5 times upper limit of normal * at screening (must be within 21 days before study entry) any clinical evidence of hiv, hepatitis b, hepatitis c or active hepatitis a infection * pregnancy (must have a negative serum pregnancy test within 21 days prior to the first dose of study drug, and urine pregnancy test must be negative on study day 0 before study entry) * history of cancer (except excision of basal cell carcinoma) * any documented immunodeficiency * a history of prior administration of monoclonal antibodies or related proteins * receipt of systemic retinoids, corticosteroids, cyclosporin a, methotrexate, phototherapy or coal tar treatment in the past 4 weeks * use of topical therapy (except emollients) for psoriasis in the past 2 weeks (certain other over-the-counter products may be allowed with prior approval of the sponsor) * receipt of any investigational drug therapy within 6 weeks before the first dose of study drug in this protocol (use of licensed agents for indications not listed in the package insert is permitted) * current or planned participation in a research protocol in which an investigational agent or therapy may be administered * nursing mother * acute illness including infections 15. clinical manifestations of significant end organ dysfunction or failure that may compromise the safety of the volunteer in the study
variable-length cognitive processing therapy for combat-related ptsd

Conditions: Posttraumatic Stress Disorder

Summary: the primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (cpt-c) in a sample of 130 active-duty service members through a variable length treatment.

the primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (cpt-c) in a sample of 130 active-duty service members through a variable length treatment. the study seeks to determine if some service members would benefit from a longer or shorter dose of treatment (4-24 sessions), and to identify which individuals are likely to require more, less, or the standard number of treatment sessions to reach good end-state functioning. predictors of length of therapy and treatment outcome will be examined. specifically, we will evaluate factors related to internalizing/externalizing traits, cognitive flexibility, inability to inhibit dysfunctional cognitions, and readiness to change as they are related to the number of treatment sessions required to treat patients to the point of good end-state functioning. additional outcomes including alcohol use, psychosocial functioning, physical health, and sleep also will be evaluated.

Eligibility criteria:
inclusion criteria: * adult male and female combat veterans who deployed in support of combat operations following 9/11 * diagnosis of ptsd determined by a clinician-administered posttraumatic stress scale (caps-5) * speak and read english exclusion criteria: * current suicide or homicide risk meriting crisis intervention. * active psychosis. * moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires). * local availability of fewer than 5 months * late-phase med board status, awaiting percentages * undergoing a chapter

Keywords: posttraumatic stress disorder cognitive processing therapy active duty military
safety of intranasal irrigation probiotics in healthy volunteers

Conditions: Sinusitis

Summary: chronic rhinosinusitis (crs) is one of the most common chronic diseases, affecting the quality of life of patients who suffer. despite medical and surgical treatments available, there are a significant number of people suffering from crs refractory to these standard treatments. a preliminary clinical trial conducted at chum hôtel-dieu, has allowed us to evaluate the therapeutic potential of intranasal irrigation of probiotics in patients with crs. this treatment administered twice daily for 14 days was well tolerated and resulted in improved chronic rhinosinusitis symptoms. prior to deployment on a larger scale, the safety of this therapy must be confirmed in a healthy population, free of sinus disease. therefore, this study aims to assess the safety of the use of probiotic intranasal irrigation in healthy volunteers.

if the participant (healthy volunteer) agrees to participate in the study, and after signing the information consent form, her/his participation in this project will consist to receive the experimental treatment of probiotics, to come to four (4) medical assessment visits at chum, over a period of time of four (4) weeks, and answer to one (1) phone call. this study will include five (5) periods : 1. determination of eligibility period (day 0) 2. saline irrigation period (day 0 to day 7) 3. elimination of saline period (day 8 to day 14) 4. probiotic treatment period (day 15 to day 21) 5. telephone follow-up period (day 22 to day 28)

Eligibility criteria:
inclusion criteria: * men and women aged 18 and older. * participant in general good health. * absence of nasal and ear signs or symptoms. exclusion criteria: * participant suffering from acute rhinosinusitis, chronic rhinosinusitis, symptomatic allergic rhinitis, or other sinus disease. * participant with diseases of the middle ear causing impairment of the eardrum or middle ear, or have had surgery of the middle ear previously, except myringotomy with insertion tube. * primary or acquired immunodeficiencies documented. * antibiotic intake within 30 days before enrollment. * unable to do nasal rinse. * pregnant woman. * smell score from upsit-40 under normal smell threshold (\<34).

Keywords: probiotics nasal irrigation healthy volunteers
a study to test different doses of bi 456906 in patients with obesity

Conditions: Obesity

Summary: main objective is to investigate the tolerability of different titration schemes of bi 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 years and \< 70 years of age at screening * body mass index (bmi) ≥ 27 kg/m2 and \<40 kg/m2 at screening * a minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening * hba1c \<6.5% * further inclusion criteria apply exclusion criteria: * women who are pregnant, nursing, or who plan to become pregnant while in the trial * supine blood pressure (bp) ≥160/100 mmhg at screening * major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * further exclusion criteria apply
anti-tumor activity of sb-485232 in patients with previously untreated metastatic melanoma

Conditions: Melanoma

Summary: this phase ii study is designed to evaluate the anti-tumor activity of three dose groups of sb-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in subjects with previously untreated metastatic melanoma.


Eligibility criteria:
inclusion criteria: * patients must have melanoma that has spread beyond the original location and has not yet been treated. * tissue from the spreading melanoma should have been tested to confirm it is melanoma. exclusion criteria: * patients having hepatitis or hiv infection. * taking corticosteroids. * patients with the primary site being occular melanoma or patients with melanoma of the brain.

Keywords: il-18 treatment naive phase 2 melanoma
the web-it clinical study

Conditions: Wide Neck Bifurcation Intracranial Aneurysms; Intracranial Aneurysms

Summary: the study is a prospective, multicenter single-arm cohort. patients with wide neck bifurcation aneurysms (wnbas) have few choices for safe and effective endovascular treatment. in this study, all patients with qualifying wnbas will be treated with the web. the primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.


Eligibility criteria:
inclusion criteria: * patient whose age ≥18 and ≤75 years. * patient must have a single ruptured or unruptured ia (intracranial aneurysm) requiring treatment. * patient must sign and date an irb/ec-approved written informed consent prior to initiation of any study procedures. exclusion criteria: * patient has an ia with characteristics unsuitable for endovascular treatment * patient has stroke-in-evolution within the prior 60 days * patient has had an sah (subarachnoid hemorrhage) from a nonindex ia or any other intracranial hemorrhage within 90 days * patient's index ia was previously treated * patient is pregnant

Keywords: aneurysm intracranial aneurysm vascular diseases cardiovascular diseases intracranial arterial diseases cerebrovascular disorders brain diseases central nervous system diseases nervous system diseases
analgesic effect of different positions and canulae on medial branch radiofrequency denervation for lumbar zygapophyseal joint pain

Conditions: Lumbar Facet Joint Pain; Lumbar Medial Branch Neurotomy

Summary: prospective study to analyse pain reduction with two types of canulae and two types of placements for lumbar medial branch radiofrequency denervation.

patients who suffer from lumbar zygapophyseal joint pain often receive radiofrequency medial branch denervation as treatment. many types if canulae exist, and many types of placing them in relation to the medial branch nerves (mb). the earl study tries to compare the analgesic effect of thin canulae (22 gauge) placed perpendicular to mb to thicker canulae (18 gauge) placed parallel to mb.

Eligibility criteria:
inclusion criteria: * low back pain of \> 3 months * 18-80 years * vas or nrs\>6 * positive controlled block exclusion criteria: * pregnancy * psichiatric disorders * not being able to fulfil questionnaires * body mass index\>35 * labor litigation * negative or non conclusive controlled block * failed back surgery syndrome

Keywords: lumbar facet joint pain lumbar medial branch neurotomy chronic low back pain